[Congressional Record (Bound Edition), Volume 154 (2008), Part 17] [Senate] [Pages 23832-23834] [From the U.S. Government Publishing Office, www.gpo.gov]PAYMENTS TO PHYSICIANS Mr. GRASSLEY. Mr. President, I have been examining several doctors at universities across the country to see if they are complying with the financial disclosure policies of the National Institutes of Health. I ask unanimous consent to have printed in the Record my latest letter to Emory University regarding Dr. Charles B. Nemeroff and the Emory- GlaxoSmithKline-National Institute of Mental Health Initiative. There being no objection, the material was ordered to be printed in the Record, as follows: U.S. Senate, Committee on Finance, Washington, DC, October 2, 2008. Hon. James W. Wagner, Ph.D., President, Emory University, Dowman Drive, Atlanta, GA. Dear Dr. Wagner: The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 80 million Americans who receive healthcare coverage under these programs. As Ranking Member of the Committee, I have a duty to protect the health of Medicare and Medicaid beneficiaries and safeguard taxpayer dollars appropriated for these programs. The actions taken by thought leaders, like those at Emory University (Emory), often have profound impact upon the decisions made by taxpayer funded programs like Medicare and Medicaid and the way that patients are treated and funds expended. I would like to expand on concerns I brought to your attention regarding problems with the disclosures of outside income filed with Emory by Dr. Charles Nemeroff, Chair of the Department of Psychiatry. I have previously cited discrepancies pertaining to Dr. Nemeroff's disclosures filed with Emory and reports that I received by several companies regarding payments made to Dr. Nemeroff. I also raised concerns about Dr. Nemeroff's conflicts of interest relating to several National Institutes of Health (NIH) grants. Federal regulations place numerous requirements on a university or hospital when its researchers apply for NIH grants. These [[Page 23833]] regulations are intended to ensure a level of objectivity in publicly funded research, and state in pertinent part that NIH investigators must disclose to their institution any ``significant financial interest'' that may appear to affect the results of a study. NIH interprets ``significant financial interest'' to mean at least $10,000 in value or five percent ownership in a single entity. From the summer of 2003 until the summer of 2008, Dr. Nemeroff was the primary investigator on a collaborative grant between Emory, GlaxoSmithKline (GSK) and the National Institute of Mental Health (NIMH)--the Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Initiative). This Initiative examined five novel GSK antidepressant candidates. The NIH budgeted approximately $3.95 million over this grant's five year period with about $1.35 million paid directly to Emory for overhead costs. Apparently, Dr. Nemeroff also received some payment for his salary from this grant, although the exact amount has not yet been made available to the Committee. On several occasions during the life of this grant, it appears that Dr. Nemeroff failed to report to Emory that he was participating actively on the speaker's bureau for GSK. For instance, in an email regarding his outside activities dated October 1, 2003, Dr. Nemeroff wrote: . . . I have to dig up the agreement and send it to you, GSK no standing contract, I chair their ad board 2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend. However, and based upon information in our possession, in 2003 GSK paid Dr. Nemeroff about $119,000 in speaking fees and expenses. Based upon information provided from Emory, Dr. Nemeroff did not report that he was giving promotional talks for GSK on Paxil and Lamictal. On March 19, 2004, Dr. Nemeroff again addressed his relationship with GSK in response to questions from Emory's Conflicts of Interest (COI) Committee. Again, it appears that Dr. Nemeroff did not mention the fees he was receiving for promotional speaking on behalf of GSK. In a letter to the Assistant Dean for Administration, Dr. Nemeroff wrote: Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year. However, on March 16, 2004, three days prior to signing this letter, GSK paid Dr. Nemeroff $3,500 for a talk he gave on Paxil at the Citrus Club, a members only business establishment in Orlando, Florida. On March 17, 2004, he gave another $3,500 talk about Paxil in Kissimmee, Florida. The week after he signed this letter, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various venues in New York State. In June 2004, Emory's COI Committee released a report on Dr. Nemeroff's company sponsored grants and outside activities. Dr. Nemeroff was provided a copy of the report which stated in pertinent part: The Committee concluded that you did not follow procedures and policies regarding the review of your consulting agreements and that you failed to disclose your potential conflicts of interest in research in your Annual Disclosure Form for 2002-2003, your Sponsored Projects Approval Forms, and your IRB and IACUC forms. In response to this report, Dr. Nemeroff wrote a memorandum to the executive associate dean on July 6, 2004, explaining how he would manage his conflicts in the future. He included the last page of the COI Committee's report with his signature to indicate ``that I will follow the management plans for my conflicts of interest.'' As part of this management plan, Dr. Nemeroff wrote, ``In view of the NIMH/ Emory/GSK grant, I shall limit my consulting to GSK to under $10,000/year and I have informed GSK of this policy.'' Barely a week after this promise, on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave regarding Paxil at the Larkspur Restaurant and Grill in Las Vegas, Nevada. The following day, Dr. Nemeroff gave two more talks in exchange for $7,000 from GSK ($3,500 per talk). On July 19, 2004, Dr. Nemeroff received an invitation from the marketing team of Lamictal to attend their national advisory board meeting on November 15-16. Dr. Nemeroff responded by email: I cannot attend this meeting, unfortunately for two reasons. First I have a prior commitment presenting grand rounds at St. Louis University on the 16th and a chairs meeting at Emory on the 15th. Secondly because I serve as the Principal Investigator of the Emory/ GSK/NIMH grant from NIH on Antidepressant Drug Discovery, I am very limited in my ability to consult with GSK as this is viewed as a conflict of interest. Records supplied from GSK show that Dr. Nemeroff was most likely in St. Louis on the 16th of November. On November 17th, GSK paid Dr. Nemeroff $7,000 for two clinical roundtables at two physicians' offices in St. Louis, and $3,500 for a lecture he gave at Kemoll's Italian Restaurant. On July 15, 2004, Emory's Office of the Dean sent Dr. Nemeroff a letter regarding the Emory-GSK-NIMH Collaborative Moods Disorders Initiative grant. The letter concerned the COI Committee's review of his relationship with GSK. The letter stated: The [COI] Committee understands that you serve on the GlaxoSmithKline Paroxetine Advisory Board and provide advice to GSK on their products that are already on the market. For these services, you receive approximately $15,000 annually. You do not have any stock options or equity interests in GSK. Please correct the record if this is not correct. . . . The [COI] Committee found that you have a significant financial interest in GSK because your consulting fees are more than the de minimis amount established by Emory's University Policy, the AAMC guidelines, and PHS regulations, which is currently $10,000 annually. . . . In order to manage this conflict of interest, the [COI] Committee requires that you keep your consulting fees from GSK to an amount equal to or less than $10,000 on an annual basis throughout the grant period, its renewals, and final collection of data. In response, Dr. Nemeroff sent a letter to the executive associate dean on August 4, 2004. Dr. Nemeroff wrote: However, to reiterate, I have already taken the necessary steps to be in compliance with the recommendations of the COI Committee, namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data. GSK has been informed of this change and certainly understand the reasons for this decision and is supportive of my compliance with the university recommendations. According to GSK reports, Dr. Nemeroff exceeded the $10,000 limit within that very same month. On August 23, 2004, Dr. Nemeroff was paid $3,500 for a teleconference with the Louisiana State University Psychiatry Department. GSK reports that this was a ``non product'' talk. However, Dr. Nemeroff gave talks on the 25th and 26th at two restaurants in New York regarding Paxil--one at Passion Fish Restaurant in Woodbury and the second at Burton and Doyles in Great Neck. For each talk, GSK paid Dr. Nemeroff a $3,500 speaking honorarium. On August 31, 2004, Dr. Nemeroff held a ``non product'' teleconference for an additional $3,500. On October 29, 2004, the assistant dean for administration sent Dr. Nemeroff a letter concerning his grants. Relying on Dr. Nemeroff's promise to maintain his consulting fees from GSK below $10,000, Emory informed him that he did not have a conflict with the Emory-GSK-NIH Collaborative Mood Disorders Institute. However, GSK reports that Dr. Nemeroff's final lecture on Paxil was given on January 26, 2006. That day he gave two talks in Springfield, Missouri. He gave one lecture at the Burrel Behavioral Health and the second at Mille's Turn of the Century Cafe. GSK paid Dr. Nemeroff $7,000 for the lectures along with $174.98 in expenses. Based upon information provided to me, it appears that Dr. Nemeroff denied giving these lectures. For instance in a letter on November 20, 2006, Dr. Nemeroff wrote the following to the Emory dean about his outside activities: ``I was somewhat surprised by the suggestion that I serve as [primary investigator] or co-PI in any research protocols funded by a company with which I have a financial relationship. This is absolutely untrue. Quite some time ago, I made that decision based on the 2004 letter from Dr. Adkison and have stuck to it. Thus, this is not an issue.'' However, during the years that Dr. Nemeroff served as the primary investigator of the Emory/GSK/NIMH Initiative it seems he failed to report approximately half a million dollars in fees and expenses from GSK. These fees covered dozens of talks given to promote drugs sold by the company. Accordingly, I request that your institution respond to the following questions and requests for information. For each response, please repeat the enumerated request and follow with the appropriate answer. (1) For each year that the Emory/GSK/NIMH grant was active, please provide the following: a. Total amount of grant; b. Amount provided to Emory for overhead; and c. Amount of grant provided as salary to Dr. Nemeroff. (2) Please provide all communications regarding this investigation and/or Dr. Nemeroff's outside consulting. This information may be held by Dr. Nemeroff and/or his assistant and/or supervisors to Dr. Nemeroff. The time span of this request covers November 2007 to the present. (3) According to documents provided to us by Emory, Dr. Nemeroff wrote a memo to himself on the letterhead of the journal Depression and Anxiety, stating that he was paying himself $3,000 to write a supplement for that journal. Dr. Nemeroff then filled out an Emory form for payment, with the money being withdrawn from Emory account 9-30410-2170. Please provide documents and explanation for the source of funds that were placed in this account. Thank you again for your continued cooperation and assistance in this matter. As you know, in cooperating with the Committee's review, no documents, records, data or [[Page 23834]] information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee. I look forward to hearing from you by no later than October 16, 2008. All documents responsive to this request should be sent electronically in PDF format to Brian_Downey@finance- rep.senate.gov. If you have any questions, please do not hesitate to contact Paul Thacker at (202) 224-4515. Sincerely, Charles E. Grassley, Ranking Member. Attachment. DR. CHARLES NEMEROFF'S DISCLOSURES ON GLAXOSMITHKLINE ------------------------------------------------------------------------ Amount Year Company Disclosure filed in company March 2008 reported ------------------------------------------------------------------------ 2000......... GlaxoSmithKline...... No amount provided $190,918 \1\. 2001......... GlaxoSmithKline...... No amount provided 135,460 \1\. 2002......... GlaxoSmithKline...... $15,000.............. 232,248 2003......... GlaxoSmithKline...... Not reported......... 119,756 2004......... GlaxoSmithKline...... $9,999............... 171,031 2005......... GlaxoSmithKline...... $9,999............... 78,097 2006......... GlaxoSmithKline...... No amount provided 32,978 \2\. ------------------------------------------------------------------------ \1\ Consulting agreement for two weekends a year. \2\ Speaker's Bureau, $3,500 per talk; $5,250 for rotating speakers series. Note 1: When a Physician named a company in a disclosure but did not provide an amount, the text reads ``no amount reported.'' When a Physician did not list the company in the disclosure, the column read ``not reported.'' ____________________